NCT03411967Unknown2 期
Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy
Zigong No.1 Peoples Hospital0 个研究点目标入组 20 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 主要终点
- ORR
研究概览
简要总结
In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected survival of not less than 12 weeks;
- •The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)
- •The main organs function properly
- •Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;
- •Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.
排除标准
- •Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;
- •Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- •Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;
- •Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- •In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;
- •Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;
- •Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- •Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);
- •Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;
- •Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g;
- •Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;
- •Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;
- •The investigators determine other situations that may affect clinical research and outcome decisions.
研究组 & 干预措施
apatinib combine with docetaxel
Experimental
Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd
干预措施: Apatinib (Drug)
apatinib combine with docetaxel
Experimental
Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd
干预措施: Docetaxel (Drug)
结局指标
主要结局
ORR
时间窗: 6 month
Objective Response Rate
次要结局
- PFS(12 month)
研究者
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